Trial Title:
Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors
NCT ID:
NCT06445062
Condition:
Colorectal Cancer
CRC
Pancreatic Ductal Adenocarcinoma
PDAC
Gastrointestinal Cancer
Metastatic Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Colorectal Neoplasms
Adenocarcinoma
Gastrointestinal Neoplasms
Paclitaxel
Bevacizumab
Gemcitabine
Cetuximab
Conditions: Keywords:
CRC
PDAC
RAS Mutation
KRAS G12X
Colorectal Cancer
Pancreatic Cancer
Pancreatic Ductal Carcinoma
KRAS Q61 Mutation
KRAS G12 Mutation
RAS Wild-type
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RMC-6236
Description:
Oral tablet
Arm group label:
Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
Arm group label:
Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
Arm group label:
Subprotocol C: metastatic PDAC
Intervention type:
Drug
Intervention name:
mFOLFOX6 regimen
Description:
IV infusion
Arm group label:
Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
Arm group label:
Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
Intervention type:
Drug
Intervention name:
bevacizumab
Description:
IV infusion
Arm group label:
Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
Intervention type:
Drug
Intervention name:
mFOLFIRINOX regimen
Description:
IV infusion
Arm group label:
Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
Intervention type:
Drug
Intervention name:
cetuximab
Description:
IV infusion
Arm group label:
Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
Intervention type:
Drug
Intervention name:
gemcitabine
Description:
IV infusion
Arm group label:
Subprotocol C: metastatic PDAC
Intervention type:
Drug
Intervention name:
nab-paclitaxel
Description:
IV infusion
Arm group label:
Subprotocol C: metastatic PDAC
Summary:
The purpose of this platform study is to evaluate the safety, tolerability,
pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors
combined with Standard(s) of Care (SOC) or with novel agents.
The first three subprotocols include the following:
Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens
Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6
Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel
Detailed description:
The platform study design allows combinations of RAS(ON) inhibitors with other anticancer
agents to be evaluated in patients with RAS-mutated solid tumors with a focus on GI
cancers.
This is an open-label platform study to evaluate the safety, tolerability,
pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors
combined with Standard of Care (SOC) or with novel agents, and to define the Recommended
Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with RAS mutations will be
specified in each subprotocol.
Subprotocol A is an open-label, multicenter study of RMC-6236 in combination with
5-fluorouracil-based regimens in patients with treatment-naïve unresectable or metastatic
colorectal cancer or treatment-naïve metastatic pancreatic ductal adenocarcinoma.
Subprotocol B is an open-label, multicenter study of RMC-6236 in combination with
cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal
cancer or patients with previously treated or treatment-naïve metastatic pancreatic
ductal adenocarcinoma. Subprotocol C is an open-label, multicenter study of RMC-6236 in
combination with gemcitabine and nab-paclitaxel in patients with treatment-naïve
metastatic pancreatic ductal adenocarcinoma. Each subprotocol consists of two parts: Part
1 - Dose Exploration and Part 2 - Dose Expansion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
All Patients (unless otherwise noted):
- ≥ 18 years of age
- ECOG PS is 0 to 1
- Adequate organ function as outlined by the study
- Pathologically or cytologically documented pancreatic carcinoma or poorly
differentiated pancreatic carcinoma with metastatic disease or RAS-mutated,
histologically or cytologically confirmed colorectal adenocarcinoma with documented
unresectable or metastatic disease (Subprotocol A, B, and C)
Exclusion Criteria:
All Patients:
- Primary central nervous system (CNS) tumors
- Impaired gastrointestinal (GI) function that may significantly alter the absorption
of RMC drugs
- Major surgery within 28 days of first dose
Other inclusion/exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth Research Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Facility:
Name:
UCLA Hematology/Oncology- Santa Monica
Address:
City:
Los Angeles
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Cincinnati Medical Center
Address:
City:
Cincinnati
Zip:
45267
Country:
United States
Status:
Recruiting
Facility:
Name:
Hospital of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Baylor College of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22314
Country:
United States
Status:
Recruiting
Start date:
May 24, 2024
Completion date:
July 15, 2027
Lead sponsor:
Agency:
Revolution Medicines, Inc.
Agency class:
Industry
Source:
Revolution Medicines, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06445062
